FDA 510(k)

X-Wire 导丝

K号: K244061 · 2025-08-26

决定日期2025-08-26

产品代码MOF

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

X-Wire Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K244061. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-Wire Guidewire?

X-Wire Guidewire is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Imperative Care, Inc.. The 510(k) number is K244061.

When did X-Wire Guidewire receive FDA 510(k) clearance?

X-Wire Guidewire received FDA 510(k) clearance on 2025-08-26, under 510(k) number K244061.

Who is the listed applicant for X-Wire Guidewire?

FDA 510(k)记录将Imperative Care, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for X-Wire Guidewire?

The FDA product code for X-Wire Guidewire is MOF.

列明Imperative Care, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261176Zoom 4S 导管 K252046Zoom系统（Zoom 4S导管）K252057Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统 K243047Zoom 7X 导管；Zoom 吸痰管；Zoom POD 吸痰管 K250775Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统 K242672缩放系统

查看所有 18 个设备 →

官方来源

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